BRPI0713758A2 - fluid purge in a medical injection system - Google Patents

Abstract

FLUID PURGE AND A MEDICAL INJECTION SYSTEM. The invention provides a method of purging air or liquid from an assisted injection system. In this embodiment, the method includes triggering a first pumping device in a first operating mode to inject a certain amount of a first liquid medium through disposable tubes and a disposable valve, and triggering a second pumping device to inject a quantity of a second medium liquid through disposable tubes and the deformed valve. In one embodiment, the first pumping device comprises a first second syringe, and the disposable valve comprises an elastomeric valve.

Description

FLUID PURGE IN A MEDICAL INJECTION SYSTEM

Field of the Invention

This application relates generally to the field of medical technology and devices, and especially to medical fluid injection systems that may be used for angiography, computed tomography (CT), or other medical procedures.

Background of the Invention

Certain medical procedures, such as, for example, injection of a contrast medium during angiographic procedures, may require that liquids (such as radiographic contrast agents) be injected into a patient's vascular system under pressure. In certain cases, liquids may be injected at pressures as high as 1200 pounds per square inch (psi) (8.27 χ 106 Pa), or possibly even higher.

During these injection procedures, it may also be desirable to measure the patient's physiological pressure for hemodynamic monitoring. For example, on angiography, it may be desirable to record intravascular and intracardiac pressures between high-pressure contrast medium injections. Pressure transducers that are designed for physiological measurements, such as hemodynamic measurements, often cannot tolerate even moderate injection pressures and therefore should normally be isolated from any high pressure flow during injection.

Brief Description of the Invention

One embodiment of the invention provides a method of air or liquid purge from an assisted injection system. In this embodiment, the method includes driving a first pumping device in a first operating mode to inject a certain amount of a first liquid medium through disposable tubes and a disposable valve, driving the first pumping device in a second operating mode to deform the valve. disposable, and actuating a second pumping device to inject a quantity of a second liquid medium through disposable tubes and the deformed valve. In one embodiment, the first pumping device comprises a first syringe, the second pumping device comprises a second syringe, and the disposable valve comprises an elastomeric valve.

In one embodiment, the type of valve that is used

In the assisted injection system is a deformable valve, such as an elastomeric valve. As used in assisted injection systems, an elastomeric valve allows to transmit liquid flow in one direction while preventing backflow in the opposite direction. According to one embodiment, before the elastomeric valve is connected to a patient, air on both sides of the valve is removed. This application discloses methods which, when performed, help to remove air from both sides of such a valve, according to some embodiments.

Various advantages and benefits are provided in certain embodiments of the invention. For example, certain modalities help remove air bubbles from lines and minimize the amount of contrast required during injection procedures. In addition, in certain modalities it may help the healthcare professional to position the catheter tip in a safe position away from direct contact with the patient's arterial vessels to help minimize the chances of complications such as dissection or perforating the wall of a vase. The fine structure content and shape of the hemodynamic signals return through the liquid-filled catheter tip to a pressure transducer that helps the clinician assess catheter position for safe injections. Several modalities help minimize signal damping that can be caused by the presence of viscous contrast or air bubbles in the line.

Brief Description of the Drawings

Figure 1 is an enlarged view of an exemplary valve assembly according to one embodiment of the present invention.

Figure 2 is a cross-sectional view taken along a normal fluid flow direction of the exemplary valve assembly of Figure 1 illustrating the normal mode of operation (low pressure).

Figure 3 is a cross-sectional view taken along a normal fluid flow direction of the exemplary valve assembly of Figure 1 illustrating the open (high pressure) mode of operation. Figure 4 is a front view of the assembly.

example of the valve of figure 1.

Figure 5 is a perspective view of an example of the valve body according to an embodiment of the present invention showing the inlet and saline ports.

Figure 6 is a top view of an exemplary valve body of Figure 5.

Figure 7 is a cross section taken from position AA of an exemplary valve body of Figure 6. Figure 8 is a detailed drawing of portion (B)

shown in figure 7.

Figures 9 (a) to (c) show different views of an exemplary disk carrier according to one embodiment of the present invention. Figures 9 (d) and 9 (e) show different examples of a valve disc according to one embodiment of the present invention.

Figures 10 (a) to 10 (g) show different alternative embodiment views of a valve assembly.

Figures 11 (a) to 11 (g) show different views of yet another alternative embodiment of a valve assembly.

Figure 12 is a block diagram of one embodiment of an assisted injection system that may be used to perform various functions and, when operable, may be coupled to a valve assembly.

Figure 13 is a block diagram of another embodiment of an assisted injection system that may be used to perform various functions and, when operable, may be coupled to a valve assembly.

Fig. 14 is a flow chart of a method that can be performed by an assisted injection system according to one embodiment.

Fig. 15 is a flow chart of a method that can be performed by an assisted injection system according to another embodiment.

Detailed Description of the Invention

Referring to Figure 1, an exemplary embodiment of a high pressure activated valve will be described. An exemplary high and low pressure elastomeric valve is comprised of a disc holder 101, a valve intermediate disc 102, and a valve body 103. Valve body 103 and disc holder 102 are made of a relatively rigid polymer, such as polycarbonate, and valve and disc 102 are molded from an elastomer, preferably silicone rubber, with a slot in the center.

Elastomeric disc 102 with slot is placed between valve body 103 and disc holder 101 and is affixed to the perimeter of the disc. Such affixing may be effected by, for example, chemical or mechanical welding, adhesion, encapsulation, or any other means known in the art. Valve body 103 and disc holder 101 are secured by, for example, ultrasonic welding, UV curable adhesive, deliasing or thread locking, or other bonding or adhesion technologies that may be known in the art. art, thus encapsulating the disc.

In an exemplary embodiment, the valve has at least two and preferably three ports communicating with the attached piping. These ports are, for example, (a) a contrast inlet port, (b) a pressure transducer port and a saline inlet, and (c) a patient or outlet port. In an exemplary embodiment of the disc holder 101 contains such a contrast input port, as is more fully shown in Figure 2, described below.

Referring to Figure 2, a valve body 203 contains a saline / transducer input 220 from a patient / outlet port 221. In addition, a hole 222 in the disc holder inlet port is tapered (in the flow direction). from right to left in Figure 2) to create a front reservoir 240 on an elastomeric disc 202 so that as fluid passes through port 222 and enters the empty reservoir, air is forced to be purged from the reservoir through disc slot 241 and valve body 203 (more precisely, the cavity in the valve body that is adapted to fluid flow). Thus, for example, in an angiographic procedure as described above, while the contrast medium fills the empty reservoirs 240 of the disc holder 201 and thus creates pressure, the elastomeric valve disc 202 folds and eventually opens the slot 241 ( certain pressure occurs, known and referred to herein as "pressure cracking") to inject fluid into the valve body. The dimensions of the reservoir allow control of pressure cracking; at a given pressure, exposing a larger disk surface to that pressure that will increase the force on a disk and thus decrease the cracking of the pressure. The situation where the slot opens and flow flows inlet port 222 through the slot in the valve body 203 is more fully shown in Figure 3, described below.

Still with reference to Figure 2, in an exemplary embodiment a valve body 203 has two internal cones. A narrow cone 205 closest to the disk 202 containing the saline port, and a second wider cone 206. In operation, the narrower cone next to disk 202 allows the saline / transducer port 220 to be sealed while the pressure builds up and before fluid passes through the disc 202. The second, larger cone 206 is associated with the cavity space created for the disc to expand and allow slot 241 to fully open. Converging angles (in the forward flow direction) also promote valve air flow so that no bubbles are left behind.

Figure 3 shows the exemplary valve of figure 2 in the flow state of the high pressure fluid described above. Referring to Figure 3, high pressure contrast fluid flows through inlet port 322. This has caused pressure applied to the right side of disc 302 to exceed the "pressure cracking" which caused disc 302 to expand in the flow direction (or to the left in figure 3), opening the disc slit 341. While the disc expanded by covering the saline / transducer port opening 320 in the valve body cavity 303. At the same time, The force maintained on the disc 302 by the incoming fluid keeps the saline port closed during flow flow at high pressure, as, for example, is experienced in contrast fluid injection. The first cone has, for example, a ring-shaped channel 350 where the saline port 320 is located, thus allowing the interior of the valve body 303 to be completely filled with the saline during initial configuration. In an exemplary embodiment, the remainder of valve body 303 and channel inlets are preferably rounded to eliminate any entrapment of air bubbles during configuration. In addition, such a channel helps air to be removed by manually applying vacuum to the syringe.

In exemplary embodiments, the valve may be used in connection with medical low pressure to high pressure fluid injections. It can also be used with CT, MR and radiological contrast medium injection systems. In addition, a two port version of the valve with the saline / transducer port elimination 320 can be manufactured economically enough to act as a check valve. This low / high pressure valve is thus inexpensive to manufacture, having a simple design consisting of three molded parts that can be assembled and fixed together.

The disc holder contains the fluid inlet port and, in exemplary embodiments, may be molded or machined from, for example, polycarbonate, PET, acrylic or any other hard polymer as may be known in the art which can withstand high pressures. . In the exemplary embodiment of the invention elastomeric discs 202, 302 are preferably circular and may be, for example, molded and cut from silicone rubber sheets or other elastomers, including, for example, polyurethane and latex. In the exemplary embodiments, the properties of a disk of elastomeric material are, for example, a durometer in the range 40 to 70A, more specifically, for example, 55A, a tensile strength of 1000-1500 psi (6.89 χ106-10). 34 χ 106 Pa), an elongation of 300700%, breaking strength 150-300 lbs / inch. In an exemplary embodiment, the disc may be 0.060 "thick or may have a range of 0.020" to 0.200 "thick depending on the durometer, and slit and fluid dimensions. In an exemplary embodiment, the slit in the middle of the disc is preferably 0.125 ", and may be 0.050" to 0.30 "longer in length. In exemplary embodiments, the disc has a working surface diameter, preferably from 0.580 "and may range from .050" to 2.00 ".

Valve body 203, 303 is molded and machined, for example, polycarbonate, PET, acrylic or other hard polymers that can withstand high pressures such as up to 1500 psi (10.34 χ 10 6 Pa). In the exemplary embodiments, it contains the fluid outlet ports .221, 321 and the saline / transducer inlet ports 220, 320. In the exemplary embodiments, the internal shape of the valve body has two cones 205, 206, the first cone. being at an angle to the vertical (i.e. from a plane that is normal for the direction of fluid flow, and substantially parallel to the plane of the disc surface when the disc is not extended as in figure 2), for example. 10 degrees to 45 degrees, and is in an exemplary embodiment of 20 degrees, with a width of, for example, 0.020 "to 0.500", and in an exemplary embodiment preferably 0.115 ". saline inlet / transducer 220, 320 are located in the first cone, so that the cone allows discs 202, 302 to close saline port 220 and 320 as fluid flows from the injection system. For example, the second cone may be at an upward vertical angle (as above), for example, 45 degrees to 90 degrees and preferably 0.161 "depth (depth is measured along fluid flow direction) to create space for the disk to expand and the slots 241, 341 open for fluid to pass through the disk.

In exemplary embodiments the valve is mounted by placing a disk 202, 302 in the valve body 203, 303. Then the disk holder 201, 301 is placed in the valve body 203, 303 and the two parts are, for example, mechanically pressed. or threaded together and further UV-bonded, ultrasonically welded or fixed by any equivalent means as may be known in the art. The disc is thus placed between the valve body and the disc holder along the entire outer edge of the disc to prevent leakage. In exemplary embodiments, the three fluid ports may have, for example, male and female Iuer threaded conveniently to attach the injection system, the patient catheter and the saline / transducer system.

Thus, the valve disc accommodates the high and low pressure fluid systems. More than one port may be provided in the valve body 203, 303, and thus may be closed or opened during injection, for example up to 4 saline inlet type ports and may be used for different purposes such as how to inject drugs, patient fluid sample and separator pressure transducer. For example, during a high or low pressure injection (although high enough to overcome pressure cracking) all of these ports can be closed simultaneously, and when the injection system is turned off all these ports will be opened or turned on and can be used. simultaneously, or as needed.

Figure 4 is a top view for viewing the contrast fluid outlet port against the direction of fluid flow. Referring to Figure 4, in addition to the contrast fluid outlet port 421, one can see channel 450, which is an annular ring whose center is the center of the contrast fluid outlet port and which is positioned relatively close to the edge. valve disc (not seen in figure 4). As described with reference to Figure 3, on channel 450 is one or more saline / pressure transducer ports 420.

Fig. 5 is a perspective view of the valve body (103 with respect to Fig. 1) showing the contrast fluid outlet port 521 as well as a saline port 520. It is understood that several saline ports could be placed anywhere within the channel (450 with respect to figure 4; 350 with respect to figure 3) as will be described below. Figure 6 is a top view of the valve body 103 and in the exemplary embodiment shown in figure 6 some representations of exemplary dimensions are shown. The total diameter of valve body 601 is shown as one unit, the diameter of the contrast fluid outlet port 621 is shown as 0.3 units, overall depth 660 (measured here along the flow direction of fluid) is shown to be 0.700 units, and the depth of the non-conical portion of the valve body 661 to be 0.35 units. It is understood that the dimensions of figure 6 are merely exemplary, and thus show an example of a relationship between the various dimensions of this apparatus. Numerous other dimensions and relationships between them are possible and may indeed be desirable depending on the context and properties of the device which should be, if desired, accentuated or diminished. For example, tapered region depth662 is a parameter that controls pressure cracking. The more space there is in the cavity on the side of the valve disc, the easier it will be for the valve disc to be driven (there is less air-supplied resistance in one cavity than other possible components), and the lesser the pressure cracking. Thus, there is an inversely proportional relationship between depth 662 and pressure cracking ("PC"). The larger the area through which a given pressure acts on the disc, the greater the force acting on the disc. Thus CP = k / depth, for some unit the constant k.

Figure 7 shows a cross section along the line AA of the valve body shown in Figure 6. Referring to Figure 7, a number of exemplary dimensional designs are shown, such as the inside diameter of the contrast medium outlet port. 701; the outside diameter of outlet port 702; the diameter of the cavity at the front edge of the cavity where the cavity connects to the contrast fluid outlet port 703; the diameter at the beginning of the second conical region in the valve body cavity 704; the diameter at the beginning of the first conical region in the valve body cavity 705; and the inside diameter of the valve body in the non-conical region 706, which is the diameter at which a particular valve disc will fit. As described above, so as not to have any liquid leakage, the diameter of an exemplary designed disc to fit within diameter 706 will be the same diameter to ensure a tight fit. It is also possible to make the disc diameter slightly larger in the exemplary alternative embodiments, thus ensuring a tight fit where low viscosity liquids are widely used which requires greater attention to prevent leakage.

Note that for the exemplary embodiment shown in Figure 7, an example of a valve disc designed to fit therein is shown in Figure 9 (d) in the horizontal top view in Figure 9 (e) in a vertical side view shown. Referring to figure 9 (d) it can be seen that the diameter of the exemplary disc valve shown is 0.83 units, identical to the dimension shown in figure 7 of element 706. As can be seen with reference to figure 7, there is a region 750 shown as being surrounded by the circle labeled "B." This region is shown in figure 8, as described below.

Figure 8B shows detailed region B on a scale enlarged by a factor 6 relative to figure 7. The area of detail shown in figure 8 is, as should be obvious to the reader, the exemplary saline port on the valve body. Referring to Figure 8, it is noted that the outer cone of the valve body is, in this exemplary embodiment, 60 degrees outside the vertical and that the distance from the corner where the outer tapered region begins at the outer surface of the valve body to The center of the saline port is, in this exemplary embodiment, 0.192 units 801. In addition, the angle .802, which represents the angles of the inner cone or the first cone 205 (with reference to Figure 2) will be shown to be .30 degrees in this exemplary embodiment. The exemplary diameter of the saline port 810 is 0.169 units, thus, with reference to figure 8, 803 indicates the depth of the channel for manually purging air from the transducer side of the system (not required if self-purging) .8 04 a primary cone of a valve body for closing a saline / transducer port during an injection, .805 a location of a transom for positively securing a valve disc, and 806 a height of a transom for securing a disc.

Referring to Figures 9 (a) to 9 (c), various views of disc holder 101 (with reference to Figure 1) are shown, with the following exemplary dimensions. Referring to Figure 9 (a), an external diameter 901 with 0.83 units. Note that this dimension corresponds to element .706 of Figure 7, which is precisely the exemplary dimension in which the inside diameter of the non-conical portion of the valve body to which the disc holder fits. As well, reference numerals 902-905 represent the exemplary inner diameter of the exemplary disc holder shown, and with reference to figure 9 (c), 910 shows an exemplary diameter of a main portion of an exemplary disc holder, .911 an exemplary outside diameter of the high pressure inlet port, 912 an exemplary inside diameter of it, 914 an exemplary port size sufficient to create pressure, 915 an exemplary reservoir size for creating pressure, and 908 an exemplary reservoir angle (in vertical) for an exemplary reservoir. With reference to figures 9 (d) and 9 (e), exemplary views and dimensions for a valve disc are shown. Referring to figure 9 (d), as explained above, an exemplary outside diameter of the valve disc is shown to be 0.83 units. The exemplary disk length is shown to be 0.15 units. Note that, given the relationship between disc length and valve disc diameter, even when the valve disc slot is fully open, there is no leakage problem in the valve disc perimeter.

Thus, one or more additional saline ports could be placed anywhere within the annular ring identified as channel 350 with respect to Figure 3, which would be identical and simultaneously closed after the valve configuration currents shown in Figure 3. Referring to Figure 9 (e), the valve disc thickness is shown and an exemplary valve disc thickness shown here in this exemplary embodiment is 0.06 units thick. Design parameters are used to define a pressure override for the valve according to one embodiment. In general pressure cracking is a function of disc thickness, slot length, elastomeric disc durometer, and primary valve body cone. Pressure cracking increases with increasing disc thickness and durometer of disc material, and decreasing pressure cracking with decreasing disc slot length and the primary cone of the valve body.

Figures 10 (a) - 10 (g) show different views of an alternative embodiment of a valve assembly. In this assembly, the valve assembly includes a valve holder or cap 1008, an elastomeric valve 1010, and a valve body or housing 1000. The assembly also includes a first inlet port 1006, a second inlet port 1004, and a outlet port 1002. Figure 10 (a) shows an exploded view of the valve assembly with each of the separate components 1000, 1008 and 1010. In this embodiment, the first inlet port is coupled to the valve holder 1008, and both the second inlet port 1004 and outlet port 1002 are attached to valve body 1000. In one embodiment, elastomeric valve1010 comprises a disc valve.

In one embodiment, the first inlet port 1006 is aligned along a first axis that is substantially tangent to valve body 1000. In one embodiment, the first axis is substantially normal and tangent to valve body 1000. In one embodiment, the first axis is substantially tangent to a particular area or volume contained in valve body 1000, and may also be substantially normal to that particular area or volume. Figure 10 (a) and Figure 10 (e) show examples of how this first axis may be substantially normal for a transverse plane of valve body 1000 (which is also co-planar with the planes through valve 1010 and valve 1008). These figures also show examples of how the first axis is also substantially tangent to valve body 1000. This configuration allows fluid to be injected into first inlet port 1006 to be tangentially injected through valve body 1000 and exit through outlet port. 1002. With this design, the valve assembly provides an efficient and effective air purge (e.g., air bubbles) from the assembly.

In a fluid injection system, air that may be contained within the valve assembly may cause some problems. For example, air can potentially interfere with and distort cardiac hemodynamic signals and signals that are detected or monitored by a pressure transducer, such as a transducer coupled to a valve assembly transducer port 1014. These hemodynamic signals are used by physicians to safely guide and place catheter tip coupled to outlet port 1002 in safe locations within the heart during a procedure. In addition, there is a risk that some air contained within the valve assembly could potentially be introduced into the patient.

In one embodiment, the second inlet port 1004 is coupled to an inlet valve port 1015 (best seen in Figure 10 (b)), the inlet valve port is aligned along a second axis that is substantially tangent to the inlet. valve body 1000. This second axis is substantially perpendicular to the first axis of the first inlet port 1006, in one embodiment. In one embodiment, the second axis is substantially tangent to a certain area or volume within the valve body 1000. By injecting the fluids through the valve assembly through the first inlet port 1006 and the second inlet port 1004, these fluids can be injected tangentially to the valve body 1000. Fluid ports are tangentially aligned, such as ports 1006 and 1004, causing medical fluids to be injected through these ports to follow 25 spiral paths according to one embodiment. This spiral fluid flow can sweep the air bubbles trapped around the valve periphery with an outlet port 102 (best seen in figure 10 (c)). This spiral action may be sufficient to remove air bubbles from the 1010 elastomeric valve in any valve mounting orientation. By improving the efficiency and effectiveness of removing air from inside the mounting valve assembly, a better hemodynamic signal can be provided to a pressure transducer that is coupled to the valve mounting transducer port 1014, and there may also be less chance air be introduced into the patient.

In one embodiment, valve holder 108 comprises a disc holder, and valve 1010 comprises an elastomeric valve disc. As best seen in figure 10 (a), valve 1010 includes one or more slots (one of these slots 1012 is shown in figure 10 (a)). In this assembly, slot 1012 is centered on valve1010. When the elastomeric valve 1010 is in a closed state, the first inlet port 1006 is isolated from the outlet port 1002 and the second inlet port 1004 (together with the pressure transducer that can be connected to the transducer port 1014). In this state, fluid may not flow from the first inlet port 1006 to outlet port 1002, but fluid (such as a diluent, saline) may flow from the second inlet port 1004 to outlet port 1002, and a transducer coupled to the transducer port 1014 may be able to detect monitored hemodynamic signals from a patient line coupled to output port 1002.

When the elastomeric valve 1010 is in an open state, the second inlet port 1004 of transducer port 1014 is isolated from the outlet port 1002 and the first inlet port 1006, while the first inlet port 1006 then becomes coupled to outlet port 1002 for fluid flow. Valve 1010 is in the open state when a fluid pressure at the first inlet port 1006 is equal to or greater than a set pressure and causes the valve to open (as caused by slot 1012 shown in figure 10 (a) to open) . In the open state, fluid may flow from the first inlet port .1006 through slit 1012 of valve 1010 in body 1000, and out of outlet port 1002, but second inlet port 1004 and transducer port 1014 are blocked. from the highest flow pressure (as, for example, to protect a pressure transducer connected to port 1014 from becoming damaged from such high pressure flow). In this mode, the assembly of the elastomeric valve shown in Fig. 10 (a) through Fig. 10 (e) operates in a manner similar to previous embodiments of the elastomeric valve (described earlier in the present application). In one embodiment, the condition of the valve (such as valve disc 1010 shown in Figure 10 (a)) is determined by a pressure applied to the first inlet port 1006 for incoming fluid. In one embodiment, the set pressure comprises a pressure cracking of the valve 1010 to cause crack 1012 to open. In one embodiment, the pressure cracking is a function of at least one of the physical properties of the elastomeric valve .1010, internal dimensions of the holder. 1008, valve body 1000 and / or valve 1010, or external dimensions of valve holder 1008, valve body 1000 and / or valve .1010.

In one embodiment, the second inlet port 1004 is coupled to a bi-directional check valve 1030 as shown in Figure 10 (f). In some embodiments, duckbill or spring-operated bidirectional check valves may be used. In other embodiments, other forms of bidirectional check valves may be used. The bidirectional check valve 1030 allows flow to flow from the external piping through said check valve at the second inlet port 1004 through the housing 1000 and out of outlet port 1002. During a high pressure injection of fluid into the along the first entry port 1006 and through the exit port. 1002, the bidirectional check valve 1030 may further serve to protect a pressure transducer coupled to transducer port 1014 from high pressures that could potentially damage the transducer. In this type of scenario, the two-way check valve 1030 can provide a pressure relief function, with the higher pressure being passed back through the housing 1000, the second inlet port 1004, the check valve 103, and the tubing that is coupled to the 1030 check valve. The tubing may be compatible enough to reduce the excess pressure that overloads the pressure transducer. In addition, in certain embodiments, the two-way check valve 1030 may provide functionality to reflect hemodynamic signals back to the transducer, thereby preventing the hemodynamic signal from becoming dampened or attenuated.

Figure 10 (b) is a front view of the valve assembly embodiment shown in figure 10 (a). As can be seen from figure 10 (b), the shaft through the gate inlet valve 1015 (which is coupled to the second inlet port 1004 and also the transducer port 1014) is running in a direction that is tangent to the valve body10. 0 0 (for example, as the tangent for a given area or volume within valve body 1000). Figure 10 (b) also shows that valve body 1000 includes various reinforcing ribs 1016. These reinforcing ribs 1016 will help reinforce and support valve body 1000 to stabilize. The ribs 1016 help to contain the high pressures such that the valve assembly does not deform or significantly burst according to one embodiment.

Figure 10 (c) illustrates a top of the valve mounting arrangement shown in Figure 10 (a). This figure shows that the first input port 1004, the second input port 1006, the output port 1002 can all be held along the parallel axis in one embodiment. Figure 10 (c) also shows transducer port 1014 in more detail. Transducer port 1014 includes a seat 1018 for coupling a pressure transducer to port 1014. An outlet port 1020 is also shown which allows air to pass through the valve assembly during use. Possible air bubbles can be vented by valve assembly through outlet port 1020 during tangential fluid injection through one or both inlet ports 1004 and / or 1006.

Figure 10 (d) shows an alternative view of the valve assembly shown in figure 10 (a). Figure 10 (a) shows an exploded view of the valve assembly components, while figure 10 (d) shows a side view of the assembled / manufactured valve assembly.

Figure 10 (e) shows a rear view of the valve assembly embodiment shown in figure 10 (a). Figure 10 (e) shows how fluid injected through the first inlet port 1006 can be injected along the axis which is substantially normal and tangent to valve body 1000 (and also substantially normal to valve holder 1008). In addition, Figure 10 (e) shows another view of how fluid injected through second inlet port 1004, and through valve inlet port 1015 can be injected along an axis (of port 1015) that is substantially tangent to valve body 1000.

Figure 10 (f) shows a view of a valve mounting embodiment that is coupled to a bi-directional check valve 1030, which has been described above. The bidirectional check valve 1030 is coupled to a second inlet port 1004.

Figure 10 (g) shows a cross-sectional view of the elastomeric valve 1010 shown in figure 10 (a), according to one embodiment. Figure 10 (g) shows an example of slot 1012 as an angled slot. In one embodiment, the angled slot 1012 resides along an axis, where the angle between this axis and the horizontal axis of Figure 10 (g) is defined to be in the order of 5 degrees to 30 degrees. In other embodiments, configurations with different angles may be used. In one embodiment, during fluid injection, the angled slot 1012 may open to allow an injector to flow through valve1010 and out of outlet port 1002 (right to left in Figure 10 (g)) .

Figures 11 (a) to 11 (g) show different views of

yet another alternative embodiment of a valve assembly. This alternative valve mounting embodiment is similar to the embodiment shown in Figures 10 (a) to 10 (g), but without the pressure transducer port. Figure 11 (a) shows an exploded view of this alternative embodiment, where a valve assembly outlet port 1120 may be coupled to a separate external transducer port and the pressure transducer. With this design, a user can couple valve mounting, external pressure transducers with different types, shapes, or designs that can be used with valve mounting to monitor the waveforms of the patient's propagated hemodynamic signals and by mounting valve (through an outlet port 1102 and outlet port 1120). The alternative valve mounting embodiment shown in FIG. 11 (a) to 11 (g) also includes a first inlet port 1106, a valve holder 1108, a second inlet port 1104, an elastomeric valve1110 (such as a disc of valve), a slot 1112 (such as a slot centered inside valve 1110), a valve body 1100, an outlet port 1102, an outlet port 1120, an inlet valve port 1115 (which is coupled to the 1120 and the second inlet port 1104), and the reinforcing ribs 1116.

In one embodiment, the second inlet port 1104 is coupled to a bi-directional check valve 1130 as shown in Figure 11 (f). In some embodiments, bi-directional duckbill or spring operated check valves may be used. In other embodiments, other forms of bidirectional check valves may be used. The bidirectional fluid check valve 1130 allows flow through external piping said check valve, at 1104 the second inlet port, through housing 1100 and out of outlet port 1102. During a high pressure injection of fluid into the Through the first inlet port 1106 and through the outlet port 1102, the bidirectional check valve 1130 may further serve to protect a pressure transducer coupled to outlet port 1120 from high pressures which could potentially damage the transducer. In this type of scenario, the two-way check valve 1130 can provide a pressure relief function, with increased pressure being passed back through the housing 1100, the second inlet port 1104, the check valve 113 0, and to outside so that the tubing is coupled to the check valve 1130. The tubing may be compatible enough to reduce excess weight on the pressure transducer. In addition, in certain embodiments, the bi-directional check valve 1130 may provide functionality to reflect hemodynamic signals back to the transducer, thereby preventing the hemodynamic signal from becoming dampened or attenuated.

Figure 11 (g) shows a cross-sectional view of the elastomeric valve 1110 shown in figure L 1 (a) according to one embodiment. Figure 11 (g) shows an example of slot 1112 as an angled slot. In one embodiment, the angled slot 1112 resides near an axis, where the angle between the axis and the horizontal axis of the figure. 11 (g) is defined to be on the order of 5 degrees to 30 degrees. In another embodiment, angles of different configurations may be used. In one embodiment, during fluid injection, the angled slot 1112 may open to allow flow from an injector through valve 1110 and exiting through outlet port 1102 (right to left in Figure 11 (g)). ).

The valve mounting embodiments shown in Figures 10 and 11, along with other embodiments, may provide several benefits. For example, medical fluids (such as contrast medium or saline), which are injected into the valve through tangentially aligned fluid inlet ports, which help to provide spiral fluid flow within the valve. Spiral fluid flow can help potentially sweep air (e.g., air bubbles) inside the valve or cling to the periphery of the outlet port safety valve. During fluid injection, there may be high velocity of fluid flow around the outer edges of the valve and as well as throughout the valve volume. This can provide certain advantages. For example, removal of the enlarged air bubble can potentially be achieved at any orientation of the elastomeric valve (depending on orientation during insertion and use as part of a fluid injection system patient kit). This advantage helps to minimize the hypothesis that air will be introduced into a patient during a medical procedure. In addition, an improved hemodynamic signal can be achieved where a patient's hemodynamic signals can be more effectively and accurately perceived and measured by a pressure transducer and the corresponding monitoring system. The hemodynamic monitoring system can then show the waveform to a physician to provide accurate pressure feedback within a patient's vascular system during a procedure. Such information can help the clinician in many ways, such as helping to alert the correct placement of the catheter in a patient (which ultimately can potentially reduce the incidence of arterial dissection).

Figure 12 is a block diagram of one embodiment of an assisted injection system 1200 that may be used to perform various functions and, when operable, may be coupled to a valve assembly within a medical sterile field, such as a a valve assembly described above. The assisted injection system 1200 shown in Fig. 12 may be used to inject medical fluid, such as contrast medium or saline, into a patient within the sterile field during a medical procedure (such as during an angiographic procedure or CT scan). A valve assembly, such as an assembly comprising an elastomeric valve, which may be coupled to the system 1200 and used within the sterile field throughout the course of a patient procedure according to one embodiment. System 1200 includes a number of components such as a control panel 1202, a manually controlled connection 1204, a manual controller 1212, a fluid reservoir 1206, a pipe 1208, a 1210 pump, a pressure transducer 1218, a fluid 1214, an injection syringe 1216, high pressure injection tubing 1222, a valve 1220, an air detector 1224, 1226 and a stopcock. In one embodiment, described in more detail below, fluid reservoir 1206 comprises a container such as a diluent bag or vial (such as a saline solution), fluid reservoir 1214 comprises a container such as , for example, a bag or bottle of contrast media, and the pump .1210 and comprises a peristaltic pump. In other embodiments, pump 1210 may comprise other types of pump devices, such as a syringe, gear, pump, or other form of displacement pump. In some embodiments, the syringe 1216 (together with its associated plungers), which is a pumping device, may be replaced by another type of pumping device that provides high pressure fluid injections to a patient. An individual pumping device is capable of operating in different or multiple operating modes. For example, a pumping device may be operable for the fluid pump when driven, or driven to move in a first direction (e.g. forward), although it may also be operable to advance in a second direction (e.g. opposite direction, backward) to perform certain functions. An operator can use the 1202 control panel to configure various parameters and / or protocols to be used during a given procedure. Pump 1210 may be used to pump saline from the patient bag through line 1208, valve 1220, and high pressure line 1222. In one embodiment, valve 1220 includes a spring-operated cylindrical gate valve as known in the art. In one embodiment, valve 1220 comprises an elastomeric valve, such as an embodiment of an elastomeric valve described in the present application. Several valve embodiments disclosed in the present application may be used within the system of FIG. 12.

In one embodiment, syringe 1216 is used to draw contrast from reservoir 1214 on syringe 1216, and to inject contrast from syringe 1216 into the patient through valve 1220 and high-pressure tubing 1222. In one embodiment, syringe 1216 is a autopurging syringe that has a contrast fill port and air bleed, and a second contrast injection port. As described above, in relation to the operation of

Of the various embodiments of a valve, valve 1220 is used to control coupling between the inlet ports for the valve and 1220 and the outlet port. In one embodiment, the inlet valve includes two ports, one that is coupled to the contrast fluid line and one that is coupled to the saline fluid line. The saline fluid line also includes a pressure transducer 1218.

The tap 1226 regulates the flow of fluids to the patient. In one embodiment, valve 1220 further allows the saline or contrast line to be coupled to the patient (high pressure tubing) on the .1222 line. When syringe 1216 is used to inject contrast medium, valve 1220 allows the contrast medium to flow to patient line 1222, but blocks the flow of saline to patient line 1222. Pressure transducer 1218 It is also blocked from patient line 1222 during high pressure injections, thus protecting the transducer 1218 from the high injection pressures that can accompany the contrast injections. When there is no contrast injection from syringe 1216, valve 1220 blocks contrast line 1220 from patient line 1222, but opens the connection between saline line (tubing) 1208 and patient line 1222. In this state, the pump 1210 is capable of injecting saline into the patient, the pressure transducer 1218 is also capable of monitoring patient haemodynamic signals across the patient line 1222, and generates representative electronic signals based on the measured pressures.

System 1200 of FIG. 12 also shows a hand controller 1212 and an air detector 1224. An operator may use the hand controller 1212 to manually control saline injection and / or contrast medium. The operator can pull one of the hand controller buttons 1212 to inject saline, and can push the other button to inject the contrast. In one embodiment, the operator may push the contrast knob to deliver variable flow contrast. The job of the operator is to push the button, the largest flow rate of the contrast medium is delivered to the patient. Other controllers, such as the foot controller, can also be used. The air detector 1224 detects possible air bubbles or columns within the high pressure piping 1222. In one embodiment, the air detector 1224 is an acoustic or ultrasonic detector. In other embodiments, the air detector 1224 may be infrared or other devices (such as optics). If the air detector 1224 detects the presence of air in the high pressure piping 1222, it generates a signal that is used to alert the operator and / or interrupt an injection technique.

Figure 13 is a block diagram of another embodiment of an assisted injection system 1300 that may be used to perform various functions and, when operable, may be coupled to a valve assembly within a sterile medical field, such as a embodiment. of a valve assembly described above. The assisted injection system 1300 shown in Fig. 13 can be used to inject medical fluid, such as contrast or saline, into a patient within the sterile field during a medical procedure (such as during an angiographic procedure or CT). . A valve assembly, such as an elastomeric valve-containing assembly, may be coupled to the 1300 system and used within the sterile field throughout the course of a patient procedure according to one embodiment.

The 1300 Dual Syringe System is a system that includes a control panel 1302 and two 1303a and 1303b motor / actuator mounts. Each of the linear actuator motors 1303a, 1303b. Each linear actuator drives a syringe plunger 13 0 8a or 13 0 8b. An individual plunger moves within the syringe barrel 1308a or 1308b, either in a forward or backward direction. When moving in a forward direction, the plunger injects fluid into the patient line or purges air from the syringe and liquid container (eg vial). When moving in the backward direction, the plunger fills the syringe 1308a, 1308b with the liquid contents of the container. Figure 13 shows two examples of such liquid containers 1304 and 1306. In one embodiment, container 1304 is a pouch or vial containing a contrast agent, container 1306 is a solvent-containing pouch or vial, such as a saline solution. In other embodiments, syringes .1308a, 13808b (together with plungers), wherein each pumping device, may separately or together comprise another form of pumping which is capable of properly injecting fluids into

flow rates / pressures / etc. such as, for example, a peristaltic pump or other form of displacement pump. An individual pumping device is capable of operating or operating in multiple or different operating modes. For example, a pumping device may be operable to pump liquid when driven, or to drive, or to move in a first direction (for example, forward), although it may also be operable to advance in the direction of a second (for example, a opposite direction, backward) to perform certain functions.

Several pinch valve / air detector assemblies are both shown in Figure 13. An pinch valve / air detection assembly 1310a is coupled between the liquid container 1306 and a syringe inlet port 1308a, and a second valve. air sensing clamp / mounting assembly 1312a is coupled between the syringe outlet port and the patient connection 1308a. A third air sensing check / assembly valve 1310b is coupled between the liquid container 1304 and a syringe inlet port 130 8b, and a fourth air sensing check / assembly valve 1312b is coupled between the outlet port 1308b and the connection to the patient. In the embodiment shown in Figure 13, each syringe 1308a, 1308b is a double port syringe. Fluid flows and is withdrawn from the syringe 1308a or 1308b from the container through the syringe inlet port, and fluid flows and is injected from syringe 1308a or 1308b through the syringe outlet port.

Each valve is an air sensing clamping / mounting valve 1310a, 1310b, 1312a, 1312b may be opened or closed by system 1300 to control fluid connections carried or left in each of the syringes 13808a .1308b. The sensors detect air in the 1310a, 1310b, .1312a, 1312b assemblies can be optical, acoustic, or any other type of sensor. These sensors help detect air that may be present in the fluid carried in or left out of the syringes 1308a, 1308b. When one or more of these sensors generates a signal indicating that air may be present in a fluid line, the 1300 system may warn the user or terminate an injection technique. The use of multiple valves in the 1300 system allows the .1300 system to automatically, or through user interaction, selectively control fluid flow into or out of syringes 1308a, 1308b by opening or closing the fluid tubing. In one embodiment, system 1300 controls each of the pinch valves. The use of multiple air detecting sensors helps to improve the safety of the 1300 system by eventually detecting air (e.g. columns, bubbles) in the fluid (in the tubing) that carries or withdraws from syringes 1308a, 1308b. Air detector signals are sent and processed by system 1300, so that system 1300 can, for example, give a warning or terminate an injection technique if air is detected. In the example of Fig. 13, the first pipe fluid passes through the pinch valve and then passes through the air detector within the assemblies 1310a, 1310b, 1312a, 1312b. In other embodiments, other configurations, arrangements, and the like may be used for valves and air detectors within these assemblies. In addition, other types of valves may be replaced by the clamping valve.

An operator may use the 1302 control panel to initialize, or configure the 1300 injection system for one or more injection procedures, and may use the 1302 control panel to configure one or more parameters (for example, flow rate, volume fluid delivery, limit pressure, rise time) of an individual injection procedure. The operator may also use panel 1302 to interrupt, resume or terminate an injection technique and begin a new process. The control panel also displays various injection-related information for the operator, such as flow, volume, pressure, rise time, procedure type, fluid information, and patient information. In one embodiment, the control panel 1302 may be attached to the patient's stretcher and electrically coupled to the main injector of the 1300 system. In this embodiment, the operator may manually move the control panel 1302 to a convenient location while still having access. all the features provided by panel 1302.

The system of Fig. 13 also includes an outlet valve 1314 coupled to the outlet lines from the syringes 1308a and 1308b. Each syringe outlet supplies injected fluid through tubing that passes an air sensing check / assembly valve 1312a or 1312b and then leads to a valve inlet 1314. In one embodiment, a fluid line for valve 1314 also includes a pressure transducer. Valve outlet port 1314 is coupled to high pressure tubing, which is used to direct fluid to the patient. In one embodiment, valve 1314 is made of a flexible material, such as an elastomeric material described in various embodiments of an elastomeric valve above. In one embodiment, valve 1314 is an elastomeric valve, such as in a valve embodiment described in the present application. Valve 1314 allows one of the fluid lines (for example, contrast line or saline line) to be coupled to the patient line (high pressure tubing). When saline solutions are contained within syringes 1308a and 1308b, respectively, valve 1314 allows contrast to flow from syringe 1308b to the patient line (assuming pinch valve 1312b in assembly 1312b is open and no air detection has occurred). ), but blocks the flow of saline from syringe 1308a to the patient line. The saline line-coupled pressure transducer (according to one embodiment) is also locked to the patient line, thus protecting the high-pressure injection transducer that can accompany a contrast injection. When there is no contrast injection from syringe 1308b, valve 1314 blocks the contrast line from the patient line, but allows a connection between the saline line from syringe 1306 to the patient line. The 1308a syringe is capable of injecting the saline into the patient (assuming the pinch valve in mount 1312a is open and no air has been detected), and the pressure transducer is also capable of monitoring the patient's hemodynamic signals, through the patient line, and generate representative electronic signals based on the measured pressures that can be processed by the 1300 system.

In one embodiment, a small control panel (not shown) provides a subset of the functions offered by main panel 1302. This small control panel may be coupled to the injector within the 1300 system. In one scenario, the operator may use a small panel to manage injector configuration. The small panel can display guided setup instructions that assist in this process. The small panel may also display certain error and troubleshooting information to assist the operator. For example, the small panel may warn the operator if there is a low contrast fluid or saline level in the fluid reservoir and / or syringes.

Figure 14 is a flow chart of a method that can be

performed by an assisted injection system according to one embodiment. This method can be performed by various assisted injection systems, such as the system shown in figure 12 or the system 1300 shown in figure 13. The determination of the actions shown in figure 14 has merely exemplary proposals. In one embodiment, assisted injection system is capable of performing the method shown in figure 14 automatically. In this assembly, the system can perform the method automatically after the valve and associated piping are installed, or after the operator requests that the method be started by manually activating the small control panel. After the method has been performed, thus preparing the system, the valve and associated components can be connected to the patient catheter line for use during a patient injection procedure according to one embodiment.

The assisted injection system may first purge the initial saline solution. Initially, the flexible valve, such as an elastomeric valve may be used in the system, may be filled with air prior to use. Typically, an operator will remove the disposable valve and associated components / tubing from a sterile pouch and connect it to the rest of the injection system. Before the valve is used for a medical procedure, it may contain air that must be purged. To help achieve this purged air, saline is injected into the valve's saline port through a pumping device such as a pump or peristaltic syringe. In an exemplary embodiment, the saline may be injected at a rate greater than 2 ml / s and with a volume greater than twice the total volume of the valve and its associated disposable tubing. In other embodiments, saline may be injected at low flow rates. This operation helps to clear air from the front (saline) side of the valve and pressure transducer, which is coupled to the saline line. After the first saline purge is performed, the front side of the valve may block the contrast of the return fluid to the transducer element. The connection to the saline pumping device is then closed to prevent further saline from being injected. For example, in the system shown in Figure 13, the pinch valve between the saline syringe outlet port and the flexible (eg elastomeric) valve may be closed.

The system also performs a contrast purge operation according to one embodiment. This is a step of injecting the strong contrast material that injects contrast from the contrast pumping device (eg syringes) through the high pressure flexible valve. In an exemplary embodiment, the contrast is injected at a rate greater than 2 ml / s and with volume greater than twice the total volume of the elastomeric valve volume. In other embodiments, the contrast may be injected at low flow rate rates. In certain situations, a smaller number of air bubbles from the contrast side of the valve may be transferred to the saline side, and may be removed by an act after the saline purge, as described below. The next act shown in the example of Figure 14 is a valve retraction operation (such as when using an elastomeric or flexible valve). During a contrast injection, the flexible valve may fill and remain partially full even when the pressure drops. The valve retraction operation retracts the valve element to create a larger space on the saline side of the valve. The final saline purge described below can then purge all remaining valve bubbles. According to one embodiment, care may be taken not to pull too far back or too fast, as this could potentially fail to draw in air bubbles from the saline side to the contrast side of the valve. In addition, vacuum pressures capable of drawing gases from the solution could be generated on the contrast side, as discussed below. The valve retraction operation is performed by retracting the plunger into the pumping device containing the contrast medium.

The system can also perform contrast pressure equalization. Retracting operation of the elastomeric valve can potentially cause vacuum bubbles to form on the (contrast) sides of the valve. If left in a vacuum state, these vacuum bubbles could remove the gases from the mixture of contrast and actual bubble form. By momentarily opening the fluid coupling (coupling) between the contrast bottle (which supplies fluid to the syringe) and the contrast syringe, then closing this coupling after a brief pause, the partial vacuum is relieved. (For example, in the system shown in Figure 13, the pinch valve between the contrast bottle and the contrast pumping device may be momentarily opened and then, after a brief pause, closed.) Vacuum bubbles may be replaced with contrast. of the contrast bottle reservoir.

The assisted injection system may also perform a final saline purging as indicated in the method shown in Figure 14. In one embodiment, the saline may be injected again at a rate greater than 2 ml / s and a volume greater than two times the total volume of the valve and flexible tubing. In other embodiments, saline may be injected at low flow rates. This operation can clear air from the front side of the valve and pressure transducer over the saline line. The entire valve and tubing can then be bubble cleaned. At this point, the valve may be securely attached to the patient's catheter according to one embodiment. In the system shown in Figure 13, all valves are closed prior to the squeeze valve and associated piping, which are connected to the patient catheter according to one embodiment. When performing contrast and saline purge operations, the system can cause contrast pumping devices or saline to operate in certain media, such as pumps that act in directions to cause fluid purge to occur. . When performing the retraction operation, the system may cause the associated pumping device (such as the contrast pumping device) to operate in other means such as moving the pump in another direction to cause the retraction. . For example, either in the 1200 or 1300 system, the system may cause the contrast pumping device (syringe as shown in the example) to move in a first direction to cause the contrast pumping device to move in a second direction. direction (eg opposite) to cause the elastomeric valve to retract.

The method shown in Fig. 14 may offer certain advantages and benefits. For example, the method when performed may provide better bubble removal in any flexible valve orientation (e.g., elastomeric) used in the system. In addition, by performing such a method, an assisted injection system can be used to help reduce the possibility that an air bubble potentially located downstream of an air detector will be injected into a patient. The system may also provide an integrally improved hemodynamic signal by removing air bubbles from the fluid line between the patient and the pressure transducer.

Fig. 15 is a flow chart of a method that can be performed by an assisted injection system according to another embodiment. This method may be performed by various assisted injection systems, such as the system shown in Fig. 1200 in Fig. 12 or the system 1300 shown in Fig. 13. The ordering of actions shown in Fig. 15 is for exemplary purposes only. Contrast injection may consist of little or many additional acts, depending on the particular use and processing of the system's hemodynamic signals. In one embodiment, the assisted injection system is capable of performing the method shown in figure 15 automatically.

As shown in Figure 15, an initial act in the method may comprise the action of contrast injection. This act includes injecting the strong contrast material that delivers the contrast to the places of interest in a patient. The assisted injection system performing the method may then, after the contrast injection procedure, pause for system relaxation. During strong contrast injection, flexible components in the contrast fluid path may face high pressures (eg 1200 psi (8.27 χ 106 Pa)) and expand with pressure. It may take some time for expanded components to relax or lose their complacency. As the components relax, the pressure decreases. Before starting a new sequence of operations, the injection system may pause for a period of time to let the pressure decrease. This pause can be a very short interval (up to zero time), or longer if the system requires it (eg available compliance, piping length, catheter size, etc.).

The system may then perform a valve retraction operation as shown in Figure 15. This retraction operation is achieved by operating the corresponding pumping device, such as by retracting a syringe plunger into the contrast syringe. The flexible valve, such as an elastomeric valve, allows the contrast flow to the patient to advance and prevents backflow. The flexible element also has a second function for deformation under high flow pressure to seal the pressure port on the front (saline) side of the valve and protect the pressure sensitive resident hemodynamic transducer element. During a contrast injection, the flexible element fills and may remain partially filled even when the pressure drops back to the patient's nominal pressure. The partially filled valve can then partially block the line to the transducer and attenuate the high frequency components of the hemodynamic signal.

The retraction operation helps to show the valve and expose the transducer element to full hemodynamic signal. While the flexible valve is closed, it expands the volume on the front side (saline) of the valve by a small amount. This small volume can be replaced by either an equal volume of saline or a complete saline drink, described below, depending on the need for hemodynamic signal quality.

In some embodiments, the assisted injection system may then perform a contrast pressure equalization act. The valve retraction operation can potentially cause vacuum bubbles to form on the back (contrast) side of the valve. If left in this vacuum state, these vacuum bubbles could potentially remove gases from the contrast mixture and form actual bubbles. By opening the valves behind the flexible (e.g., elastomeric) valve, such as by opening a connection between the contrast bottle and the contrast pumping device, partial vacuum can be relieved. Vacuum bubbles are replaced by contrast with the contrast bottle reservoir. After a short pause to allow the vacuum to level, the valves behind the flexible valve can be closed again. In some embodiments, the method of Fig. 15 need not necessarily include the act of contrast pressure equalization.

Retracting the valve may also cause vacuum bubbles to form in the contrast pumping device. The small bubbles that were potentially present in the pumping device may expand under vacuum and consolidate into a larger bubble. A small injection of contrast into the contrast bottle may remove this air. Thus, as shown in Figure 15, a contrast bottle pushing operation is performed according to some embodiments. The assisted injection system causes the pumping device (such as, for example, to extend the plunger into the contrast syringe in a small amount) to push air into the pumping device into the vial. After a short pause to allow the pressure to equalize, any valve between the contrast pumping device and the vial may be closed. In some embodiments, the method of Fig. 15 need not necessarily include the act of pushing a contrast bottle.

The assisted injection system may perform a saline operation. Small diameter catheters filled with viscous contrast can attenuate hemodynamic signals. Injecting enough saline to replace contrast in the catheter with saline increases the hemodynamic signal. Consequently, the volume of saline may be adjusted to the size of the catheter. In one embodiment, the assisted injection system is capable of automatically determining saline volume based on pre-existing knowledge of catheter size. For example, an operator may initially use the control or smaller panel for catheter size input, which can then be used later by the saline system in determining beverage volume. In another scenario, the system is able to automatically determine catheter size by reading the information directly from the disposable catheter being used. For example, the catheter tubing packaging may include a barcode that can be read using a barcode reader installed in the system. Barcodes containing various information about disposable catheter tubing, including size, that could be used by the system. Catheter-associated RFID tags can also be used to provide information to the system in one embodiment.

When performing saline or contrast injection operations, the system may cause contrast or saline pumping devices to operate in certain media, such as pumps that circulate in specific directions to cause injection or saline drink to occur. When performing a retraction operation, the system may cause the associated pumping device to operate in other modes, such as by moving the pump in another direction to cause retraction. For example, either on the 1200 or .1300 system, the system may cause the contrast pumping device (syringe as shown in the example) to move in one direction during the first injection, but cause the pumping device of contrast move in a second direction (eg opposite) to cause elastomeric valve to retract.

The method shown in Figure 15, when performed by an injection system, can provide several benefits and advantages. For example, using the system may reduce the risk to patients due to improper catheter placement. Air bubbles may interfere and distort the cardiac hemodynamic signals being monitored. These signals can be used by doctors to guide and safely insert the catheter tip into safe places within the heart. Implementing the method shown in Figure 15 (or similar method) can help improve hemodynamic signal integrity by removing air bubbles in the system and / or disposable tubing that are used to deliver fluid to the patient.

The present invention has been described in connection with exemplary embodiments and preferred embodiments and embodiments, by way of example only. It will be understood by those skilled in the relevant art that modifications to any of the preferred embodiments or embodiments may be readily made without materially departing from the scope and spirit of the present invention as defined by the appended claims.

Claims (31)

1. Air or liquid purge method from an assisted injection system, the method, being characterized by comprising: driving a first pumping device in a first operating mode to inject a certain amount of a first liquid medium through disposable tubes and a disposable valve; driving the first pumping device a second operating mode to deform the disposable valve; and operating the second pumping device to inject an amount of a second liquid medium through the disposable tubing means and the deformed valve. Method according to claim 1, characterized in that: driving the first pumping device in the first operating mode comprises driving the first pumping device in a first direction, and driving the first pumping device in the second mode. The operating system comprises driving the first pumping device in a second direction. Method according to claim 2, characterized in that the first direction is opposite to the second direction. Method according to claim 1, characterized in that the disposable valve comprises an elastomeric valve. A method according to claim 1, characterized in that: the first pumping device comprises a first syringe with a plunger therein, and the second pumping device comprises a second syringe with a plunger therein. 6. Assisted injection system, characterized by comprising: a first pumping device, and a second pumping device, wherein the system is operable to: drive a first pumping device into a first operating device to inject an amount of a first liquid medium through disposable tubes and a disposable valve; driving the first pumping device in a second operating mode to deform the disposable valve; and actuating the second pumping device to inject an amount of a second liquid medium through the disposable tubing means and the deformed valve. A system according to claim 6, characterized in that: the first pumping device comprises a first syringe with a plunger therein, and the second pumping device comprises a second syringe with a plunger therein. System according to claim 6, characterized in that the disposable valve includes an elastomeric valve. 9. Air or liquid bleed method from an assisted injection system, the method being characterized by: extending a plunger within a first syringe to inject a certain amount of a first liquid medium through disposable tubes and a disposable valve ; retracting the plunger into the first syringe to deform the disposable valve, and after retracting, extend the plunger into a second syringe to inject a certain amount of a second liquid medium through the disposable tubing means and the deformed valve. A method according to claim 9, characterized in that the first syringe and the second syringe are different syringes, and that the first liquid medium and the second liquid medium are different liquid media. A method according to claim 9, further comprising: prior to retracting the plunger into the first syringe, extending the plunger within the second syringe to inject a second amount of the second liquid medium through the disposable tubing means. and the disposable valve. A method according to claim 9, characterized in that the disposable valve comprises an elastomeric valve. A method according to claim 9, characterized in that the elastomeric valve comprises a first inlet port coupled to the first syringe, a second inlet port coupled to the second syringe, an outlet port, and a valve disc. elastomeric. A method according to claim 9 further comprising: prior to extending the plunger within the second syringe to inject the amount of the second liquid medium through the disposable tubing means and the deformed valve, momentarily a coupling opening between the first syringe and a fluid reservoir supply fluid to the first syringe, and close the coupling between the first and the syringe to the fluid reservoir. A method according to claim 9, further comprising: after extending the plunger within the first syringe to inject the amount of the first liquid medium through the disposable tubing means and the disposable valve, pause for a period of time. 16. Fluid valve assembly, characterized in that it comprises: a valve holder; an elastomeric valve, a valve body; a first gateway; a second inlet port and an outlet port, wherein the first inlet port is aligned along a first axis that is substantially tangent to the valve body. Fluid valve assembly according to claim 16, characterized in that the first axis is substantially normal and tangent to the valve body. Fluid valve assembly according to claim 16, characterized in that the first axis is substantially tangent to a certain area or volume in the valve body. Fluid valve assembly according to claim 16, characterized in that it comprises: the valve holder comprises a disc holder, and the elastomeric valve comprises an elastomeric valve disc. Fluid valve assembly according to claim 19, characterized in that the elastomeric disc valve includes a slot. Fluid valve assembly according to claim 20, characterized in that the slot comprises an angled slot. Fluid valve assembly according to claim 16, characterized in that the second inlet port is coupled to a valve inlet port, the valve inlet port being aligned along a second axis which is substantially tangent to the valve body. Fluid valve assembly according to claim 22, characterized in that the first axis is substantially perpendicular to the second axis. Fluid valve assembly according to claim 22, characterized in that the second axis is substantially tangent to a certain area or volume in the valve body. Fluid valve assembly according to claim 16, characterized in that the second inlet port is coupled to a pressure transducer. Fluid valve assembly according to claim 16, characterized in that: when the elastomeric valve is in a closed state the first inlet port is isolated from the outlet port and the second inlet port, and when the elastomeric valve is in an open state the second inlet port is isolated from the outlet port and the first inlet port, the valve being in the open state when a fluid pressure equals or exceeds a set pressure this first port is applied inlet to cause the valve to open. Fluid valve assembly according to claim 26, characterized in that the valve disc condition is determined by a pressure applied to the first inlet port. Fluid valve assembly according to claim 26, characterized in that the defined pressure comprises a valve pressure cracking. Fluid valve assembly according to claim 28, characterized in that the pressure cracking is at least a function of the properties of the elastomeric valve, the internal dimensions of the valve holder, valve body and / or valve. , or external dimensions of the valve holder, valve body and / or valve. Fluid valve assembly according to claim 16, characterized in that it further comprises a bi-directional check valve coupled to the second inlet port for the protection of the high pressure pressure transducer, which is also coupled to the second one. Gateway. Fluid valve assembly according to claim 16, characterized in that it further comprises a bi-directional check valve coupled to the second inlet port to reflect hemodynamic signals towards a pressure transducer which is also coupled to the second port. input.